Methotrexate (stable dose) and folic/folinic acid are continued as background therapy.

Drug: SAR153191 (REGN88)

Pharmaceutical form:solution

Route of administration: subcutaneous

Experimental: SAR153191 drug product 2

SAR153191 drug product 2 in a single injection.

Methotrexate (stable dose) and folic/folinic acid are continued as background therapy.

Drug: SAR153191 (REGN88)

Pharmaceutical form:solution

Route of administration: subcutaneous

Detailed Description:

The duration of the study period per subject is 5-7 weeks broken down as follows:

Screening: 1 to 14 days,

Treatment: 1 day (2 overnight stays at the study site),

Follow-up: up to 5 weeks after dosing (an additional outpatient follow-up may be scheduled depending on the last results).

Eligibility

Ages Eligible for Study:

18 Years to 75 Years (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion criteria:

Diagnosis of rheumatoid arthritis (RA) > or = 3 months duration.

Treated for a minimum of 12 weeks with Methotrexate (MTX) prior to randomization. Treatment must be continued on a stable dose for the duration of the study.

Exclusion criteria:

Autoimmune disease other than RA.

History of acute inflammatory joint disease other than RA.

Surgery within 4 weeks prior to the screening visit or with planned elective surgery within the next 3 months.

Latent or active tuberculosis.

Fever (≥38 C) or persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the screening visit, or history of frequent recurrent infections.

Received administration of any live (attenuated) vaccine within 3 months prior to the randomization visit (eg, varicella-zoster vaccine, oral polio, rabies).

Received tuberculosis vaccination within 12 months prior to screening

Prior therapy with a Tumor Necrosis Factor (TNF) antagonist or any other biologic agents within 3 months prior to inclusion.

Known latex sensitivity.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01328522